Temp. Manager Medical Operations
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary . Contractor to manage the operations for upcoming Heath Economics studies, Phase 4 studies and other projects within Medical Affairs organization. Manager will be responsible for leading operational activities across assigned projects including study start up activities, timelines, budgets and reports. This position requires experience and expertise working across functions with internal stakeholders, alliance partners, and vendor management. Candidate must have strong interpersonal skills as well as written and oral communication skills. Duties . Demonstrated ability to manage clinical studies and projects. Incumbent will manage multiple studies/projects including . Lead study teams and coordinate activities in order to meet timelines and deliverables. Work collaboratively with medical directors and team members to ensure study s are on track according to timelines, issues are identified and escalated appropriately, and deliverables are clearly communicated . Manage vendors from vendor selection thru contracting and study implementation. Ensure study deliverables from the vendor s are met as outlined in the SOW . Manage study start-up activities including RFP process, contracting, weekly team meetings internal & external . Regular tracking and reporting of progress for these activities, including timelines, metrics and other reporting as required. Ability to understand reporting requirements and provide clear, concise reports to manager . Manage study budgets - reporting on actuals, accruals and projections . Other project-related support of MA functions . incumbent may also support projects such as compassionate use requests . presentations slides preparation . training meetings . budget planning, web portal, investigator-initiated study management, and audit activities . Requirements . Education Bachelor's Degree . Master's, PhD or PharmD a desirable plus . Experience 5 - 8 years' experience working in area s of research and/or regulatory and/or a field-based function in pharmaceutical and/or biotech company . Active working experience and/or courses pertaining to clinical research and/or MA areas such as GCP, Investigator Initiated Studies . medical/educational grants administration . medical information . registries . OIG/PhRMA guidance. Ideally, the incumbent will have a science background with active experience in aforementioned areas, ideally in the therapeutic areas of inflammation/immunology/antibody research . Incumbent must have track record of working well in a dynamic environment, must be self-motivated, able to work with a limited amount of supervision after the initial on-boarding period and enjoy working with different stakeholders clinical, pre-clinical, commercial, external customers . At least 5 years' experience being a study lead on Ph4 Study . This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.